A Phase 4 interventional study of Rivaroxaban in Cerebral Infarction and TIA, sponsored by General Hospital of Shenyang Military Region. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by General Hospital of Shenyang Military Region · Phase 4, Interventional, and Treatment
Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and national guidelines for the management of anticoagulation recommend that most of AF patients with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days of symptom onset, while European guidelines recommend that the timing of the initiation of non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction or TIA is association with stroke severity in light of the "1-3-6-12" principle. However, there are still many problems about the use of NOACs in ischemic stroke with AF. for example, it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks. Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need is to develop a guideline-based specific regimen in which the benefit-risk factors are further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score.
Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot. ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased bleeding risk compared with warfarin. Recent study indicates that early administration with rivaroxaban for AF patients within 14 days of onset does not significantly increase hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in China.
Therefore, the investigators conduct a multicenter cohort study to investigate the safety of early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.
813 studies on the registry are indexed under Cerebral Infarction; 181 are open to participants now.
This study's enrollment of 400 is above the median of 120 across 532 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
15-20 mg rivaroxaban daily
Drug: Rivaroxaban
Rivaroxaban 15-20 mg daily
incidence of intracranial hemorrhage
Time frame: 7 days
incidence of early neurological deterioration
2 or more increase in NIHSS
Time frame: 7 days
recurrence of stroke or other vascular events
Time frame: 90 days
bleeding event
Any bleeding event except intracranial hemorrhage
Time frame: 90 days
Serious adverse events
Time frame: 90 days
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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General Hospital of Shenyang Military Region